FASTER APPROVAL URGED FOR AIDS, CANCER DRUGS

Steven MorrisCHICAGO TRIBUNE

Pharmaceutical industry leaders expressed cautious support Wednesday for a report urging that President Bush cut red tape and boost funding for the Food and Drug Administration to speed approval of drugs that fight AIDS and cancer.

Cutting the time and effort required to gain approval for these and other new drugs could not only save lives, but also lop millions of dollars from the development cost of new drugs.

The National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS said the FDA should be more flexible in its policies and communicate more directly with drug developers ''to assure swifter approval of promising new therapies.''

The committee, formed in 1988 at the request of then-Vice President George Bush, recommended ways to modify the complex procedures through which drugs must pass before becoming available for patients with terminal illnesses.

The report did not address application of similar modifications to approval of other drugs, but some critics have suggested a general revision of FDA procedures is needed.

Speeding up the process likely would result in a flood of lawsuits from people experiencing unanticipated side effects from the new drugs, however, warned one drug industry lawyer.

If the FDA relaxes its procedures, ''everybody will have to take into account that the price of drugs is going to include the increased insurance claims,'' said George Burditt, a partner in the firm Burditt Bowles & Radzius. ''When we see the enormous verdicts that people get, those are paid by the overwhelming majority of people who are helped by the drug,'' he said.

Burditt said that while the public ''has been demanding that the FDA speed up its procedures, it also is demanding virtually no risk'' from the drugs.

The FDA is ''caught between a rock and hard place,'' said Ira S. Loss, a health-care analyst for the Washington Analysis Group.

''The FDA is not unnecessarily slow,'' he said. ''This country requires two well-controlled studies that demonstrate safety and effectiveness. Our requirements are stricter than other countries`.''

The report released Wednesday suggested that potential recipients of AIDS and cancer drugs would be willing to accept increased risk.

Even if the FDA requirements were revised, the agency would remain hindered by a lack of resources, said Loss.

''Staffing levels are 10 percent below where they were a decade ago,'' he said. ''The budget was cut during the Reagan years. It is testimony to the FDA`s abilities that they are able to push 20 to 25 new chemical entities out the door each year.''

Development of a new drug costs an average of $231 million and takes an average of 12 years, according to a study by the Center for the Study of Drug Development at Tufts University.

A reduction of one year in the time for approval could cut the cost by $12 million, according to the study.

These costs ''inevitably affect both the search for new, improved medicines and the cost to the consumer of such new drugs,'' said Dr. Louis Lasagna, director of the center.

He headed the committee that reported to Bush Wednesday.

Figuring the cost of drug development, and therefore the price to consumers, ''must take into account those new drug projects that are terminated without winning marketing approval,'' said Dr. Joseph DiMasi, lead author of the Tufts study.

''There`s clearly a sense at Searle that there is some streamlining to be done (at the FDA),'' said Bruno. ''We haven`t seen the report and can`t comment specifically on the details.''

The U.S. Public Health Servie is reviewing the report, said spokesman James Brown.

''Under the Reagan and Bush administrations the FDA has been moving mountains to get AIDS drugs approved in the shortest amount of time possible,'' he said. The ''parallel tracking'' process has been instituted to allow persons with life-threatening diseases to use drugs that have not completed the approval process, Brown noted.

The committee also recommended Wednesday that the cost of ''legitimate investigational drugs that meet certain requirements'' be covered by Medicare, Medicaid and private insurance.